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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K013554
Device Name POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
Maxter Glove Manufacturing Sdn Bhd
6th Miles Off Jalan Meru
Klang Selangor,  MY 41050
Applicant Contact STANLEY THAI
Correspondent
Maxter Glove Manufacturing Sdn Bhd
6th Miles Off Jalan Meru
Klang Selangor,  MY 41050
Correspondent Contact STANLEY THAI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/25/2001
Decision Date 01/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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